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Table 1 FDA-approved therapeutic drugs for lung cancers

From: Small-molecule inhibitors, immune checkpoint inhibitors, and more: FDA-approved novel therapeutic drugs for solid tumors from 1991 to 2021

Drug (brand name)

Sponsor

Properties

Indication

Approval date

Review

Vinorelbine tartrate

(Navelbine)

Pierre Fabre

Microtubule-destabilizing agent

NSCLC

12/23/1994

P

Gefitinib (Iressa)

AstraZeneca

EGFR inhibitor

NSCLC

05/05/2003

P

Erlotinib HCl (Tarceva)

OSI Pharmas

EGFR inhibitor

NSCLC

11/18/2004

P

Afatinib dimaleate (Gilotrif)

Boehringer Ingelheim

EGFR, HER2, and HER4 inhibitor

Metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) mutation

07/12/2013

P, O

Osimertinib mesylate (Tagrisso)

AstraZeneca

EGFR inhibitor

NSCLC with EGFRT790M mutations

11/13/2015

P, O

Dacomitinib (Vizimpro)

Pfizer

EGFR inhibitor

EGFR-mutated NSCLC

09/27/2018

P, O

Necitumumab (Portrazza)

Eli Lilly

EGFR-directed mAb

NSCLC

11/24/2015

S, O

Amivantamab (Rybrevant)

Janssen Biotech

EGFR- and MET-bispecific antibody

EGFR exon 20-mutated NSCLC

05/21/2021

P

Mobocertinib succinate (Exkivity)

Takeda

EGFR inhibitor

EGFR exon 20-mutated NSCLC

09/15/2021

P, O

Crizotinib (Xalkori)

Merck & Co

Multitarget TKI (ALK, ROS1, and MET)

ALK-positive advanced or metastatic NSCLC

08/26/2011

P, O

Ceritinib (Zykadia)

Novartis

Multitarget TKI (ALK, IGF1R, INSR, and ROS1)

ALK-positive metastatic NSCLC

04/29/2014

P, O

Alectinib HCl (Alecensa)

Roche

ALK inhibitor

NSCLC

12/11/2015

P, O

Brigatinib (Alunbrig)

Takeda

Multitarget TKI (ALK, EGFR, IGF1R, FLT3, and ROS1)

ALK-positive NSCLC

04/28/2017

P, O

Lorlatinib (Lorbrena)

Pfizer

Multitarget TKI (ALK and ROS1)

ALK-positive NSCLC

11/02/2018

P, O

Capmatinib HCl (Tabrecta)

Novartis

MET inhibitor

NSCLC

05/06/2020

P, O

Tepotinib HCl (Tepmetko)

Emd Serono

MET inhibitor

NSCLC

02/03/2021

P, O

Selpercatinib (Retevmo)

Loxo Oncology

RET inhibitor

RET fusion-positive NSCLC and thyroid cancer

05/08/2020

P, O

Pralsetinib (Gavreto)

Genentech

RET inhibitor

RET fusion-positive NSCLC

09/04/2020

P, O

Entrectinib (Rozlytrek)

Genentech

Multitarget TKI (TRKs, ROS1, and ALK)

NTRK fusion-positive solid tumors and ROS1-positive NSCLC

08/15/2019

P, O

Sotorasib (Lumakras)

Amgen

KRASG12C inhibitor

KRASG12C-mutated NSCLC

05/28/2021

P, O

Topotecan HCl (Hycamtin)

Novartis

DNA topoisomerases inhibitor

Relapsed SCLC

05/28/1996

P

Lurbinectedin (Zepzelca)

Jazz

DNA alkylating drug

SCLC

06/15/2020

P, O

  1. ALK Anaplastic lymphoma kinase; EGFR Epidermal growth factor receptor; HER2/4 Human epidermal growth factor receptor 2/4; IGF1R Insulin-like growth factor-1 receptor; INSR Insulin receptor; NSCLC Non-small-cell lung cancer; NTRK Neurotrophic tyrosine receptor kinase; O Orphan; P Priority; RET Rearranged during transfection; ROS1 ROS proto-oncogene 1; S Standard; SCLC Small-cell lung cancer; TKI Tyrosine kinase inhibitor; TRKs Tropomyosin receptor kinases